Dublin (Hybrid model)
Clinical Operations Manager (COM)
1. Biological/ life sciences, pharmacy, chemistry and/or medical or nursing background.
2. Minimum of one year clinical research experience or equivalent.
• Maintain knowledge of ICH-GCP, applicable regulatory requirements and guidelines, SOPs (Standard Operating Procedures), study protocols and study-specific procedures.
• Monitor clinical trial sites for assigned studies under the supervision of the study manager or senior team member in line with ICH-GCP, applicable regulatory requirements and guidelines, SOPs, study protocols and study-specific procedures.
• Perform initiation, monitoring and close out site visits
• Prepare reports of initiation, monitoring and close-out visits and follow-up on outstanding issues as per the study monitoring plan.
• Perform monitoring and reconciliation of Serious Adverse Events (SAEs).
• Collect and maintain essential documents as required by ICH-GCP, Cancer Trials Ireland and/or Sponsor SOPs and regulatory requirements/ethics committees.
• Prepare and review study related documentation as applicable (Patient Information Leaflets, Informed Consent Forms, Protocols, Case Report Forms and others) under the supervision of the study manager or senior team member.
• Communicate on study issues internally at Cancer Trials Ireland and/or with Sponsor (if applicable)
and with Investigator and site staff.
• Track clinical trial activities.
• Assist with training, mentoring and development of new and junior staff members.
• Meet regularly with the Clinical Project Manager/Trial Coordinator for assigned studies to review/update on the status of studies regularly and upon request.
• Input into SOP development where appropriate.
• Contribute to preparation for audits and inspections as required.
• Organise and attend Investigator meetings if applicable.
• Prepare and make presentations as required.
• Perform other tasks as specified by COM.
Cancer Trials Ireland welcomes applications from candidates seeking part-time working arrangements. In addition, Cancer Trials Ireland offers flexible/hybrid working arrangements for all vacancies.